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Clinical Trials/NCT06961838
NCT06961838CompletedNot Applicable

The Effect of Inspiratory Muscle Training With Substance Use Disorder

Uskudar University1 site in 1 country35 target enrollmentStarted: July 3, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
35
Locations
1
Primary Endpoint
Functional exercise capacity

Study Overview

Brief Summary

The aim was to investigate the effectiveness of inspiratory muscle training on dyspnoea, pulmonary function, respiratory muscle strength, cough capacity, functional exercise capacity, substance craving, depression, anxiety and quality of life in individuals with substance use disorder.

Detailed Description

In recent years, substance use has increased among young people in our country, and studies investigating the negative effects of substances on pulmonary health have also increased. It has been emphasized in the literature that the most appropriate features should be determined for the exercise program in the treatment of individuals with SUD. Although studies in the literature have reported that substance use affects respiratory functions and creates a restrictive or obstructive pattern, no study investigating the effects of inspiratory muscle training has been found in the literature. To our knowledge, this study is the first to examine the effects of inspiratory muscle training on respiratory function in individuals with SUD. In our study, it was assumed that inspiratory muscle training could be a simple and inexpensive technique to improve dyspnea, respiratory functions, respiratory muscle strength, cough capacity, and exercise capacity in individuals with SUD, reduce substance cravings, increase quality of life, and reduce depression and anxiety, thus making it suitable for routine clinical use. The aim was to examine the effectiveness of inspiratory muscle training on dyspnea, respiratory functions, respiratory muscle strength, functional exercise capacity, substance craving, anxiety, depression, and quality of life in individuals with substance use disorders.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Being older than 18 years
  • •Meeting the current Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for Substance Use Disorder
  • •Receiving inpatient treatment
  • •Substance use for more than one year
  • •Being able to follow simple instructions
  • •Not having any visual and auditory pathology
  • •Being able to cooperate with the devices used.

Exclusion Criteria

  • •Failure to comply with the treatment and assessment program
  • •Participation in a structured physiotherapy/exercise program in the last 6 months
  • •Presence of current psychotic symptoms
  • •Presence of any physical disability or medical problem
  • •Presence of respiratory system problems such as asthma and tuberculosis and infectious health problems (e.g. HIV, hepatitis B).

Arms & Interventions

Inspiratory muscle training group

Experimental

In addition to their standard treatment, individuals in the inspiratory muscle training group will participate in inspiratory muscle training for a total of 30 minutes with a threshold loading device (POWERbreathe®) for 15 minutes twice a day, 5 days a week for 4 weeks under the supervision of a physiotherapist.

Intervention: Inspiratory muscle training programme (Other)

Control group

Active Comparator

Individuals in the control group will continue their standard treatment.

Intervention: control group (Other)

Outcomes

Primary Outcomes

Functional exercise capacity

Time Frame: 4 weeks

Functional exercise capacity will be assessed using the 6-Minute Walk Test (6-MWT) performed using standard protocols in accordance with American Thoracic Society guidelines.

Dyspnea

Time Frame: 4 weeks

Participants' perceptions of dyspnoea in daily life will be assessed using the Modified Medical Research Council Scale (mMRC), which consists of five statements describing the full range of dyspnoea from none (Grade 0) to almost complete incapacity (Grade 4).

Respiratory Functions (FEV1)

Time Frame: 4 weeks

Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, forced expiratory volume in 1 second (FEV1) will be recorded.

Respiratory Functions (FVC)

Time Frame: 4 weeks

Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, forced vital capacity (FVC) will be recorded.

Respiratory Functions (FEV1/FVC)

Time Frame: 4 weeks

Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, FEV1/FVC ratio will be recorded.

Respiratory Functions (FEF 25-75%)

Time Frame: 4 weeks

Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, forced expiratory flow (FEF 25-75%) will be recorded.

Respiratory Functions (PEF)

Time Frame: 4 weeks

Based on ATS and ERS recommendations, a portable spirometer (Cosmed Pony FX, Rome, Italy) will be used to assess pulmonary function testing. At the end of the pulmonary function test, peak expiratory flow (PEF) will be recorded.

Respiratory Muscle Strength

Time Frame: 4 weeks

The respiratory muscle strength of the participants will be assessed by maximal inspiratory (MIP) and expiratory intraoral pressures (MEP).

Cough Capacity

Time Frame: 4 weeks

Participants' peak cough flow will be measured using a Peak Flow Meter (The Mini-Wright Standard, Cartel Business Estate, Edinburgh Way, Harlow) while individuals are making a maximal cough effort after as deep an inspiration as possible.

Secondary Outcomes

  • Penn Substance Craving Scale(4 weeks)
  • Health-related quality of life(4 weeks)
  • Anxiety and Depression(4 weeks)

Investigators

Sponsor
Uskudar University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beyzanur Dikmen

Research Assistant

Uskudar University

Study Sites (1)

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